Neoadjuvant Treatment Modalities in Esophageal Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    2000
  • sponsor
    Chinese Academy of Medical Sciences
Updated on 6 April 2021

Summary

Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.

Details
Condition Surgery, Surgical aspects, Esophageal Diseases, Esophageal Cancer, Surgery, head and neck cancer, Immunotherapy, Esophageal Carcinoma, Chemoradiation, Chemotherapy Effect, Chemoradiotherapy, Targeted Therapy, Esophageal Disorders, esophagus cancer, oesophageal cancer, immunotherapies, cancer of the esophagus, oesophageal carcinoma, surgical procedures, surgical treatment, surgeries, surgical procedure, Esophagogastric Juction Cancer
Treatment Surgery, Nimotuzumab, Immunotherapy, Platinum Based Chemotherapy, Paclitaxel based chemotherapy, Radiotherpay, 5-FU Analog based chemotherpay
Clinical Study IdentifierNCT04821843
SponsorChinese Academy of Medical Sciences
Last Modified on6 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years
Esophageal or Esophagogastric cancer
Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa (AJCC 8th)
Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences
ECOG PS score: 0~1
Estimated survival time 3 months
Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit
Informed consent

Exclusion Criteria

With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc
Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
Existing active infection such as active tuberculosis and hepatitis
History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin
Participation in other clinical trials currently or within 4 weeks of selection
Pregnant or lactating females
Absence of medical records
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